Safety in numbers

Americans are in danger of over-regulating the drug industry. There is a better way

“THE dose makes the poison,” was the advice of Paracelsus, one of medicine's most famous practitioners. In other words, anything powerful enough to help also has the power to harm. It is a rule which applies equally to prescription drugs, and to government regulation of drugmakers. America has, in recent years, been a far friendlier place for drug firms than Europe, with its penny-pinching price controls, restrictions on direct-to-consumer advertising and other curbs on the market in medicines. But now American politicians, from state capitals to Capitol Hill, are clamouring for more control over drugs—especially when it comes to safety and pricing.

Last month, yet another new product—Tysabri for multiple sclerosis—fell by the wayside. And in September, Merck withdrew Vioxx, its new anti-inflammatory medicine, because of potentially lethal cardiovascular complications. This event prompted a heated debate over the value, not just of Vioxx and its COX-2 inhibitor cousins, but of America's drug-regulatory system as a whole.

These developments, and growing arguments about the price of drugs, have tarnished the image of the industry (see article). A poll last month by the Kaiser Family Foundation found that 70% of Americans surveyed think that drug firms put profits before people. On the other hand, the poll found that almost four-fifths of respondents remain confident in the ability of the Food and Drug Administration (FDA), the industry's primary regulator, to ensure that prescription drugs are safe. The challenge now lies in keeping this faith.

Strong medicine

The recent outbreak of drug withdrawals is not the first, and will not be the last, as medical science grapples with complex diseases in more complex ways. Tools are emerging that will help detect and reduce some of these risks. But to pick up every side-effect of a new drug before it is allowed on to the market would require huge and protracted clinical trials. This would not only delay potentially useful therapies, to the detriment of patients whom no other treatment can help, but would also increase the costs of drug development to a point where drugmakers shy away from projects unless they are guaranteed top dollar for the new product—far from a sure thing in today's cost-conscious health-care climate.

Bringing a drug to market, and keeping it there, depends on striking the right balance between risk and benefit. America urgently needs better ways to continue assessing this balance once prescription drugs have been approved by the FDA. The creation of a new safety board within the agency, announced last month, could be a step forward, provided it has enough power to monitor, and control, prescription drugs once on the market. To do its job properly, such a safety board needs more and better information about the effects of drugs in real-life medicine. This means, for example, stronger incentives for doctors to report side-effects they encounter in routine practice. The FDA also needs more leverage—and possibly new legislation—to deal with drug firms in regard to post-marketing studies, labelling, advertising and withdrawals.

But this greater focus on risk needs to be balanced by a clearer view of benefits. Various efforts are under way in America to assess the cost-effectiveness of medical treatments—and prescription drugs in particular. Other countries do this already. Such assessments are a step in the right direction, especially since the information they generate could usefully inform America's current debate over drug pricing. At the moment, much of the negotiation between those who make and those who pay for America's drugs comes down to price—the lower, the better. What is needed is more systematic, rigorous and impartial assessment of the benefits of prescription medicines and a willingness to pay top dollar for those drugs which truly represent an advantage over existing treatments, and less for those that do not.

Stronger FDA enforcement of post-marketing studies and stronger signals from payers—especially the federal government, which will cover much of elderly America's drug bill from 2006—are needed to encourage drug firms to provide rigorous, unbiased evidence of the cost-effectiveness of their new products. This is something drug firms ought to welcome, despite short-term costs. In the long run, it is better for them, as well as for the public, to have pricing based on reliable evidence than on politicians currying popular favour. An industry which prides itself on science should surely welcome a more scientific approach to its own regulation.